Elizabeth Lara

Divisional Supplier Quality Engineer @MilliporeSigma

San Diego County, CA, US
MOBILE NUMBERS
+16•••••••92

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WORK HISTORY

Oct 2022 — Present

Divisional Supplier Quality Engineer @MilliporeSigma

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Responsibilities include maintaining and ensuring that the LS SQM program is compliant to Merck KGaA Darmstadt, Germany corporate group quality standards. Perform training, to LS sector sites, assess compliance, monitor and assist these sites in the implementation of all aspects of their SQM program. Having direct responsibility as SME consultant for the implementation of the SQM program with continued monitoring of 13 sites globally (China, Singapore, Western Europe and multiple US). Responsibilities can also include negotiation of agreements with suppliers; risk assessments based upon supply chains and inventory items purchased; responses to internal, customer and regulatory audit observations concerning supplier quality. Certified Supplier Quality Auditor providing support in on-site supplier audits.

SKILLS

Pharmaceutical IndustryChange ControlQuality AuditingCorrective and Preventive Action (Capa)FdaIso 13485TrackwiseComputer System ValidationAseptic ProcessingValidationGmpGlpGxpBiopharmaceuticalsStandard Operating Procedure (Sop)SopU.s. Food and Drug Administration (Fda)Quality System21 Cfr Part 11Good Laboratory Practice (Glp)BiotechnologyV&VLife SciencesCapaQuality AssuranceMedical DevicesVerification and Validation (V&V)

ABOUT ELIZABETH LARA

Experienced Quality Professional with a demonstrated history of working in the…

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